Efficacy of Arnica montana D4 for healing of wounds after Hallux valgus surgery compared to diclofenac

J Altern Complement Med. Jan-Feb 2008;14(1):17-25. doi: 10.1089/acm.2007.0560.

Abstract

Objective: This study was undertaken to answer the question: "Is Arnica D4 as efficacious as diclofenac in relation to symptoms and wound healing after foot surgery?"

Methods: In this randomized double-blinded, parallel-group study (GCP-standard), the efficacy of Arnica D4 10 pillules (taken orally, 3 times per day) and diclofenac sodium, 50 mg (taken orally, 3 times per day) were investigated for equivalence in 88 patients 4 days after hallux valgus surgery. Outcome parameters were (1) postoperative irritation, (2) patient mobility, (3) rated pain, and (4) use of analgesics. The hierarchic equivalence test based on one-sided Wilcoxon-Mann-Whitney-U confidence intervals (CIs) was used. Equivalence was perceived, when the lower margin of the 95% CI was > 0.36 corresponding to a range of equivalence of 1/2 standard deviation.

Results: Arnica D4 and diclofenac were equivalent for wound irritation (lower margin of the 95% CI on day 4: 0.4729 for rubor; 0.3674 for swelling; 0.4106 for calor) and patient mobility (0.4726). A descriptive analysis showed the superiority of Arnica D4 with respect to patient mobility (p = 0.045). With respect to pain, Arnica D4 was inferior to diclofenac (lower margin of the 95% CI 0.026). No significant differences were found regarding the use of additional analgesics during the 4 postoperative days (Dipidolor, Janssen-Cilag, Neuss, Germany; p = 0.54; Tramal, Grünenthal, Aachen, Germany; p = 0.1; and Novalgin, AVENTIS-Pharma, Bad Soden, Germany; p = 0.1). Arnica D4 was significantly better tolerated than diclofenac (p = 0.049). Nine (9) patients (20.45%) of the diclofenac group and 2 (4.5%) of the Arnica D4 group reported intolerance. There was no disturbance in wound healing in any of the patients. Arnica D4 is 60% cheaper than diclofenac.

Conclusions: After foot operations, Arnica D4 can be used instead of diclofenac to reduce wound irritation.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Arnica*
  • Diclofenac / therapeutic use*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Hallux Valgus / surgery*
  • Humans
  • Male
  • Pain Measurement / drug effects
  • Pain, Postoperative / drug therapy
  • Pilot Projects
  • Plant Extracts / therapeutic use
  • Treatment Outcome
  • Wound Healing / drug effects*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Plant Extracts
  • Diclofenac